2025 Global Harmonization Center International Workshop (Pharmacovigilance)
Date: November 3–4, 2025 (Mon–Tue)
Place: Sky31 Convention, Lotte World Tower, Seoul, Korea
Theme: Evaluation of WLA Vigilance and Strengthening Global Regulatory Cooperation
1st Day – November 3
Agenda for Day 1 (November 3, 2025) of the 2025 Global Harmonization Center International Workshop (Pharmacovigilance), including session titles, speakers, videos, and materials
| No. |
Title |
Speaker |
| 1 |
Overview of WHO GBT and WLA |
Dr. Rogerio Gaspar
(WHO)
|
|
|
| 2 |
Sharing of WLA Designation Case |
Dr. Juhyun Baek
(MFDS)
|
|
|
| 3 |
GBT Evaluation for WLA Designation
|
| • WLA Evaluator’s Perspective: Dr. Anna Laura Salvati (WHO) |
Dr. Anna Laura Salvati
(WHO)
|
|
|
| • WLA Candidate’s Perspective: Jiae Kim (MFDS) |
Jiae Kim
(MFDS)
|
|
|
| • WLA Candidate’s Perspective: Dr. Hyunju Chung, Hyuna Bae (KIDS, Korea) |
Dr. Hyunju Jung
(KIDS, Korea)
|
|
|
| • WLA Candidate’s Perspective: KDCA |
Hyuna Bae
(KDCA)
|
|
|
| 4 |
Special Session |
| • Pharmacovigilance through AI and Digital Transformation |
Dr. Min-kyung Shin (Seltasquare, Korea) |
|
|
| • ADB’s effort to strengthen the regulatory system in ASIA |
Dr. Jae kyoun Kim (ADB) |
|
|
2nd Day – November 4
Agenda for Day 2 (November 4, 2025) of the 2025 Global Harmonization Center International Workshop (Pharmacovigilance), including session titles, speakers, videos, and materials
| No. |
Title |
Speaker |
| 5 |
WLA Vision and Global Cooperation
|
| • WLA Key Focus‧Desired Objective |
Dr. Rogerio Gaspar
(WHO)
|
|
|
| • WLA Projected Impacts |
Youngjin Choi
(Eubiologics, Korea)
|
|
|
Helene Sou
(Takeda, Singapore)
|
|
|
| • Panel Discussion: Discussion on WLA and Global Collaboration |
Participants |
|
|
2025 Global Harmonization Center International Workshop
(Medical Device Vigilance)
Date: November 4, 2025 (Mon–Tue)
Place: Sky31 Convention, Lotte World Tower, Seoul, Korea
Theme: Evaluation of Medical Device Vigilance and Strengthening Global Regulatory Cooperation
Agenda for November 4, 2025 of the 2025 Global Harmonization Center International Workshop (Medical Device Vigilance), including session titles, speakers, videos, and materials
| No. |
Title |
Speaker |
| 1 |
(Singapore)
Medical Device Vigilance in Singapore’s HSA
|
Siaw Kai Lun
(HSA, Singapore) |
|
|
| 2 |
(EC)
Medical Device PV Management System
|
Jeppe Larsen
(Danish Medicines Agency, Denmark) |
|
|
| 3 |
(TGA)
Medical Device PV Management System
|
Dr. Marcelle Noja
(TGA, Australia) |
|
|
| 4 |
(South Korea)
Medical Device PV Management System
|
Dr. Yoonsook Kim
(NIDS, Korea) |
|
|
| 5 |
(South Korea)
Case Studies of Global Medical Device Regulatory Guidelines Application
|
Dr. Sengchan You
(NIDS, Korea) |
|
|
| 6 |
(South Korea)
Experience Sharing on Global Medical Device Market Entry & MDV
|
Honggu Lee
(Osstem Korea, Korea) |
|
|
| 7 |
(Panel Discussion)
Panel Discussion: Global RSS Solutions in the Medical Device Field
|
Participants |
|
|
